Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Thyroid Stimulating Hormone changes
研究概览
简要总结
The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)
详细描述
In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women between the ages of 18 and 75;
- •Diagnostic criteria for mild subclinical hypothyroidism :TSH>10mIU/L, thyroxine and free thyroxine levels were normal
- •Positive thyroglobulin antibody and/or Thyroperoxidase antibody
- •No previous use of drugs affecting thyroid function
排除标准
- •The contraindications indicated in the Chinese instructions of the drug
- •Liver function impairment
- •Renal function impairment
- •Claustrophobia
- •Mental disorders
研究组 & 干预措施
levothyroxine sodium
levothyroxine sodium
干预措施: Levothyroxine Sodium Tablets (Drug)
结局指标
主要结局
Thyroid Stimulating Hormone changes
时间窗: Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
free thyroxine changes
时间窗: free thyroxine changes from baseline and 12 weeks during follow-up
free thyroxine changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes
时间窗: Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI
时间窗: T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
次要结局
- anti-thyroid peroxidase antibody changes(anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up)
- anti-thyroglobulin antibody changes(anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up)
研究者
Guang Wang
Director of Endocrinology
Beijing Chao Yang Hospital